Elecsys CA 15-3 II

Basic Information

• Brand Name: Elecsys CA 15-3 II
• Primary DI: 04015630939961
• Version / Model: 07027001190
• Catalog Number: 07027001190
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-15
• Public Version: 4
• Public Version Date: 2018-07-19
• Public Version Status: Update
• Public Device Record Key: 39e677bb-9e6e-4408-a645-7d1ebe12af36

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOI	SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR	Immunology	866.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54571	Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630939961	GS1

Premarket Submissions

Submission Number	Supplement Number
K171605	000
K181492	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius